1.0 Purpose: This SOP describes the guidelines for the visual inspection to be carried out during the production (filling of bottles) of oral liquids.

2.0 Scope: This SOP applies to Quality Control Chemist, Production Chemist & Operating staff

3.0 Responsibility:  It is the responsibility of the Production Chemist to ensure that the procedure is followed.

4.0 Materials and Equipment: Visual inspection unit with white & black back-ground.

5.01 Hold 4 bottles (10 to 60ml fill) or 2 bottles (100 to 200ml fill) or 1 bottle (more than 200ml fill) in hand.

5.02 Gently shake the filled bottle(s) and keep in inverted position.

5.03 Check the contents of the liquid alternatively in white & black background and discard the bottles containing any visible particles.

5.04 Check for proper seal on bottles.

5.05 Check for any visible mark or crack on bottles.

5.06 In case of suspension, check for homogeneity of suspension.

5.07 Check that the volume of the filled contents in the bottle is not less or much more than standard / stated volume for bottles.

5.08 Recover the contents of bottles so rejected & record in the in-process control records.

5.09 Person(s) doing visual inspection should perform this operation for not more than 4 hours at a stretch and he / she should be periodically monitored for proper eyesight.

FAQs for Visual Inspection of Filled Bottles SOP

Q1: Why is visual inspection of filled bottles important? A: Visual inspection ensures the quality and integrity of filled bottles, helping to identify and address defects or anomalies that may affect product safety and customer satisfaction.

Q2: What are the key aspects covered in the Visual Inspection of Filled Bottles process? A: The process covers verification of batch details, appearance and labeling, fill level inspection, seal integrity, checking for foreign particles, and cap inspection.

Q3: How should I prepare for Visual Inspection of Filled Bottles? A: Ensure the inspection area is clean and well-lit. Verify that all necessary equipment, such as magnifying glass and inspection table, is in good working condition.

Q4: What should I look for during appearance and labeling inspection? A: Inspect for visible defects such as cracks or scratches. Verify the accuracy and placement of labels to ensure they adhere to approved specifications.

Q5: What actions should be taken if a defect is found during inspection? A: Document the defect, report findings to the relevant department, and initiate corrective actions. Rejected bottles should be clearly marked, segregated, and properly disposed of.

Q6: Is training required for personnel conducting Visual Inspection of Filled Bottles? A: Yes, personnel involved in visual inspection should be adequately trained and certified for the task. Regular reviews and updates to training programs are essential.

Q7: How often should the SOP be reviewed and updated? A: The SOP should be regularly reviewed, and updates should be made as needed to reflect changes in procedures, equipment, or regulations.

Q8: What records need to be maintained for Visual Inspection of Filled Bottles? A: Detailed records, including batch details, inspection findings, and any corrective actions taken, should be maintained for effective documentation.

Q9: Can a bottle with an underfilled or overfilled content be accepted? A: No, bottles with underfilled or overfilled contents should be discarded during the inspection process to maintain product quality and consistency.

Q10: How can I obtain a copy of the SOP? A: Copies of the SOP can be obtained from the designated personnel responsible for document distribution within the company.

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